【正文】 defects, deviations and allocation of resources.傳統(tǒng)上，對(duì)于質(zhì)量的風(fēng)險(xiǎn)的評(píng)估和管理是基于多種非正式的方式(經(jīng)驗(yàn)的，和/或，內(nèi)部程序)，例如，現(xiàn)象匯總、趨勢(shì)和其它資料。此類方法繼續(xù)提供有用的信息，這些信息可以支持諸如處理投訴、質(zhì)量缺陷、偏差與資源分配。Additionally, the pharmaceutical industry and regulators can assess and manage risk using recognized risk management tools and/ or internal procedures (., standard operating procedures). Below is a nonexhaustive list of some of these tools (further details in Annex 1 and chapter 8):此外，制藥業(yè)界與藥政可以使用公認(rèn)的風(fēng)險(xiǎn)管理工具，和/或，內(nèi)部程序(例如，標(biāo)準(zhǔn)操作程序)來評(píng)估和管理風(fēng)險(xiǎn)。以下并非是這些工具的一個(gè)詳盡的列表(詳細(xì)在附件 1 和第 8 章)：? Basic risk management facilitation methods (flowcharts, check sheets etc.)。基本風(fēng)險(xiǎn)管理簡(jiǎn)易方法(流程圖，核對(duì)單等)；? Failure Mode Effects Analysis (FMEA)。 故障模式效應(yīng)分析(FMEA)；? Failure Mode, Effects and Criticality Analysis (FMECA)。 故障模式影響與嚴(yán)重性分析(FMECA)；? Fault Tree Analysis (FTA)。 故障樹分析(FTA)；? Hazard Analysis and Critical Control Points (HACCP)。 危害分析關(guān)鍵控制點(diǎn)(HACCP)；? Hazard Operability Analysis (HAZOP)。 危害及可操作性分析(HAZOP)；? Preliminary Hazard Analysis (PHA)。 預(yù)先危險(xiǎn)分析(PHA)；? Risk ranking and filtering。 風(fēng)險(xiǎn)排行與過濾；? Supporting statistical tools. 輔助性統(tǒng)計(jì)工具。It might be appropriate to adapt these tools for use in specific areas pertaining to drug substance and drug (medicinal) product quality. Quality risk management methods and the supporting statistical tools can be used in bination (., Probabilistic Risk Assessment). Combined use provides flexibility that can facilitate the application of quality risk management principles.在原料藥和藥物(醫(yī)療)產(chǎn)品質(zhì)量的特定領(lǐng)域運(yùn)用這些工具可能是恰當(dāng)?shù)摹Ｙ|(zhì)量風(fēng)險(xiǎn)管理方法以及輔助統(tǒng)計(jì)工具可以聯(lián)合使用(如，概率性風(fēng)險(xiǎn)評(píng)估)。聯(lián)合使用提供了靈活性，而這種靈活性可以促進(jìn)質(zhì)量風(fēng)險(xiǎn)管理原則的應(yīng)用。The degree of rigor and formality of quality risk management should reflect available knowledge and be mensurate with the plexity and/ or criticality of the issue to be addressed.質(zhì)量風(fēng)險(xiǎn)管理的嚴(yán)格程度與和形式應(yīng)當(dāng)反映可利用的知識(shí)和所關(guān)注問題的復(fù)雜性，和/或嚴(yán)重性相當(dāng)。6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPERATIONS 質(zhì)量風(fēng)險(xiǎn)管理與業(yè)界及藥政運(yùn)行整合Quality risk management is a process that supports sciencebased and practical decisions when integrated into quality systems (see Annex II). As outlined in the introduction, appropriate use of quality risk management does not obviate industry’s obligation to ply with regulatory requirements. However, effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a pany’s ability to deal with potential risks, and might affect the extent and level of direct regulatory oversight. In addition, quality risk management can facilitate better use of resources by all parties.質(zhì)量風(fēng)險(xiǎn)管理是一個(gè)過程，當(dāng)將其整合到質(zhì)量體系中時(shí)(見附錄 II)可以支持基于科學(xué)和實(shí)踐的決策。正如在簡(jiǎn)介中所簡(jiǎn)述的，恰當(dāng)?shù)剡\(yùn)用質(zhì)量風(fēng)險(xiǎn)管理并不能免除業(yè)界遵守藥政的要求。然而，有效的質(zhì)量風(fēng)險(xiǎn)管理可以促使做出更好和更有遠(yuǎn)見的決策，它可以為管理者提供業(yè)界更多的應(yīng)對(duì)潛在風(fēng)險(xiǎn)能力的保證并且可能會(huì)影響直接監(jiān)管的范圍和水平。另外，質(zhì)量風(fēng)險(xiǎn)管理可以促使資源能被所有部門更好地運(yùn)用。Training of both industry and regulatory personnel in quality risk management processes provides for greater understanding of decisionmaking processes and builds confidence in quality risk management outes.對(duì)業(yè)界以及藥政人員進(jìn)行質(zhì)量風(fēng)險(xiǎn)管理的培訓(xùn)可以更好地了解決策過程，并且對(duì)質(zhì)量風(fēng)險(xiǎn)管理的結(jié)果建立信心。Quality risk management should be integrated into existing operations and documented appropriately. Annex II provides examples of situations in which the use of the quality risk management process might provide information that could then be used in a variety of pharmaceutical operations. These examples are provided for illustrative purposes only and should not be considered a definitive or exhaustive list. These examples are not intended to create any new expectations beyond the requirements laid out in the current regulations.質(zhì)量風(fēng)險(xiǎn)管理應(yīng)該與現(xiàn)有的運(yùn)作和相應(yīng)文件系統(tǒng)恰當(dāng)整合。附錄 II 提供了一些用到質(zhì)量風(fēng)險(xiǎn)管理過程狀況的例子，其可對(duì)不同的藥品運(yùn)作提供信息。所提供的這些例子只是出于說明的目的，其不應(yīng)該被認(rèn)為是一個(gè)權(quán)威性的或詳盡的列表。而且它們也沒有試圖建立任何新的超越當(dāng)前管理文件中列出的要求的期望。Examples for industry and regulatory operations (see Annex II):業(yè)界與藥政運(yùn)作的例子(見附錄 II)：? Quality management. 質(zhì)量管理。Examples for industry operations and activities (see Annex II):業(yè)界運(yùn)作與活動(dòng)的例子(見附錄 II)：? Development。 開發(fā)；? Facility, equipment and utilities。 設(shè)施、設(shè)備與公共設(shè)施；? Materials management。 物料管理；? Production。 生產(chǎn)；? Laboratory control and stability testing。 實(shí)驗(yàn)控制和穩(wěn)定性試驗(yàn)；? Packaging and 。Examples for regulatory operations (see Annex II):藥政運(yùn)作的例子(見附錄 II)：? Inspection and assessment activities. 檢查活動(dòng)與評(píng)估活動(dòng)。While regulatory decisions will continue to be taken on a regional basis, a mon understanding and application of quality risk management principles could facilitate mutual confidence and promote more consistent decisions among regulators on the basis of the same information. This collaboration could be important in the development of policies and guidelines that integrate and support quality risk management practices.當(dāng)藥政決策將會(huì)持續(xù)在某個(gè)區(qū)域基礎(chǔ)上應(yīng)用時(shí)，對(duì)質(zhì)量風(fēng)險(xiǎn)管理原則的一般了解和應(yīng)用可以在相同的信息基礎(chǔ)上促進(jìn)管理者之間的相互信心并且促使他們做出更一致的決策。這個(gè)合作對(duì)于整合和支持質(zhì)量風(fēng)險(xiǎn)管理實(shí)踐的政策和指南的開發(fā)非常重要。7. DEFINITIONS 定義Decision Maker(s): 決策者：Person(s) with the petence and authority to make appropriate and timely quality risk management decisions.有能力和權(quán)力做出恰當(dāng)?shù)牟⒓皶r(shí)的質(zhì)量風(fēng)險(xiǎn)決策的人。Detectability: 可檢測(cè)性：The ability to discover or determine the existence, presence, or fact of a hazard.發(fā)現(xiàn)或確定危險(xiǎn)存在，出現(xiàn)或事實(shí)的能力。Harm: 傷害：Damage to health, including the damage that can occur from loss of product quality or availability.對(duì)健康的損害，包括可能由于產(chǎn)品質(zhì)量或有效性損失引起的損害。Hazard: 危險(xiǎn)：The potential source of harm (ISO/IEC Guide 51).潛在的傷害來源(ISO/IEC 指南 51)。Product Lifecycle: 產(chǎn)品生命周期：All phases in the life of the product from the initial development through marketing until the product’s discontinuation.從最初的開發(fā)到上市，直到產(chǎn)品的停止這個(gè)產(chǎn)品生命的所有階段。Quality: 質(zhì)量：The degree to which a set of inherent properties of a product, system or process fulfills requirements (see ICH Q6A definition specifically for quality of drug substance and drug (medicinal) products.)對(duì)于一個(gè)產(chǎn)品，系統(tǒng)或過程實(shí)現(xiàn)需求的內(nèi)在性質(zhì)程度(見 ICH Q6A definition specifically for “quality” of drug substance and drug (medicinal) products)。A systematic process for the assessment, control, munication and review of risks to the quality of the drug (medicinal) product across the product lifecycle.用于評(píng)估，控制，溝通和評(píng)審藥物(醫(yī)療)產(chǎn)品貫穿整個(gè)產(chǎn)品生命周期質(zhì)量風(fēng)險(xiǎn)的一個(gè)系統(tǒng)化過程。Quality System